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Relapsed Adult ALLPhase 1NCT04516551

Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT

A Phase 1 study testing anti-CD19 allo-CAR-T cells in people with Relapsed Adult ALL and B Cell Leukemia, run by Xinqiao Hospital of Chongqing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The patients with relapsed B cell acute lymphoblastic leukemia (ALL) after hematopoietic stem cell transplant (HSCT) have a poor prognosis, especially for these relapsed in a short time after transplantation. Nowadays there is no effective way to salvage patients in such conditions. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Relapsed Adult ALL, B Cell Leukemia
What is being tested?
anti-CD19 allo-CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
20 Nov 2020to 1 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of relapsed B-cell acute lymphoblastic leukemia (B-ALL).
  • Patients have received hematologic stem cell transplantation from matching sibling donor or unrelated donor.
  • CD19-positive tumor (>20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）
  • Hgb ≥ 7.0 (can be transfused)
  • Life expectancy greater than 12 weeks
  • Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.

Who cannot join

  • Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years)；
  • Severe mental disorders；
  • A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
  • Subjects with II-IV grade acute graft versus host disease GVHD (Glucksberg Standrad) or chronic GVHD.
  • Heart disease with grade III-IV heart failure [NYHA classification], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission；
  • Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed)；
Show all 18Show fewer
  • Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
  • Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
  • Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
  • Active infection requiring systematic treatment within 2 weeks before single collection；
  • Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy；
  • History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years；
  • Presence of pulmonary fibrosis；
  • Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer)；
  • Subjects with poor compliance due to physiological, family, social, geographical and other factors, or those unable to cooperate with the study plan or follow-up；
  • At the discretion of the investigator, there are complications requiring systemic corticosteroid therapy (≥ 5mg / day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after this clinical research treatment；
  • The lactating woman who is reluctant to stop breastfeeding；
  • Any other condition considered unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country.

Xi Zhang, MD phD contact

13808310064 ext. +86

zhangxxi@sina.com

Ruihao Huang contact

18984398751 ext. +86

1169731117@qq.com

China1 site, 1 recruiting

  • Department of Hematology, Xinqiao Hospital

    Chongqing, Chongqing Municipality, 400037

    Ruihao Huang, 18984398751 ext. +86, 1169731117@qq.com

    Recruiting

Other trials in China

About this study

Official title: Anti-CD19 Donor-derived CAR-T Cells for Patients With Relapsed B Cell Malignancies After Hematopoietic Stem Cell Transplantation: a Multi-center, Uncontrolled Trial.

The patients with relapsed B cell acute lymphoblastic leukemia (ALL) after hematopoietic stem cell transplant (HSCT) have a poor prognosis, especially for these relapsed in a short time after transplantation. Nowadays there is no effective way to salvage patients in such conditions. T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability, which makes it serve well for patients with relapsed B-ALL. So we launched a multi-center clinical trial to proved the safety and efficacy of anti-CD19 CAR-T cells for relapsed B cell ALL.

Read the detailed description

The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, for B-ALL patients suffered from relapse after allo-HSCT (hematopoietic stem cell transplant), the T cells derived from healthy donor seems like a better origin for CAR-T cells producing because T cells derived from healthy matched sibling or unrelated donors have not been restrained by tumor micro-environment and retain anti-leukemia ability. So after we designed a clinical trial to manifest the safety and efficacy of anti-CD19 CAR-T cells for patients with relapsed B cell ALL.

Being tested
anti-CD19 allo-CAR-T cells
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD19 allo-CAR-T cellsBiological

    The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.

Study groups in NCT04516551
Study groupRoleWhat they receive
anti-CD19 allo-CAR-TExperimentalThe study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determining optimal dosage. dosage: the number of anti CD19+CD22 CAR T cells -1(if needed) 1×10^6/KG 3×10^6 /KG 6×10^6 /KG 1×10^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days or bendamustione (90mg/m2 per day) for two days prior to cell infusion.
Receives: Biological: anti-CD19 allo-CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the safety of anti-CD19 allo CAR-T cells

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: within 4 weeks after infusion

  2. the efficacy of anti-CD19 allo CAR-T cells

    ratio of bone marrow blast cells

    Measured: 4 weeks after infusion

Secondary outcomes (1)

  1. The long-term efficiency

    ratio of bone marrow blast cells

    Measured: up to 2 years after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2020
  2. Study start20 Nov 2020 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04516551
Sponsor's protocol ID
Anti-CD19 allo-CAR-T
Status last verified
Nov 2020
First submitted
13 Aug 2020
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luo Y, Gao L, Liu J, Yang L, Wang L, Lai X, Gao S, Liu L, Zhao L, Ye Y, Wang M, Shen L, Cao WW, Wang D, Li W, Zhang X, Huang H. Donor-derived Anti-CD19 CAR T cells GC007g for relapsed or refractory B-cell acute lymphoblastic leukemia after allogeneic HSCT: a phase 1 trial. EClinicalMedicine. 2023 Dec 21;67:102377. doi: 10.1016/j.eclinm.2023.102377. eCollection 2024 Jan.

    PubMed 38204488

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CD19 allo-CAR-T cells in people with Relapsed Adult ALL and B Cell Leukemia, run by Xinqiao Hospital of Chongqing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xi Zhang, MD phD (13808310064 ext. +86, zhangxxi@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the safety of anti-CD19 allo CAR-T cells (time frame: within 4 weeks after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04516551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

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